MR Guided Focused Ultrasound Surgery in the Treatment of Uterine Fibroids: Software V4.2 Validation
Completed · Phase 3
Conditions studied: Uterine Fibroids, Uterine Leiomyomas
In brief
The goal of this study is to validate the new ExAblate Application software V4.2 by developing additional data that shows the safety of this treatment. The ExAblate is intended to ablate uterine fibroid tissue in pre- or peri-menopausal women with symptomatic uterine fibroids who desire a uterine sparing procedure. Patients must have a uterine size of less than 24 weeks and not seeking treatment for reasons of improving fertility.
Key facts
- Study ID
- NCT00295217
- Run by
- InSightec
- People needed
- 15
- Starts
- 2006-02-01
- Expected to finish
- 2006-10-01
- Last updated by the study team
- 2018-12-20
Who can join
Age: 18 and older. Sex: female. Healthy volunteers: accepted.
You may qualify if…
- Women who present with symptomatic uterine fibroids and are not seeking treatment for the reason of improving fertility.
- Able and willing to give consent and able to attend all study visits.
- Patient is pre or peri-menopausal (within 12 months of last menstrual period).
- Able to communicate sensations during the ExAblate procedure.
- Uterine fibroids, which are device accessible (i.e., positioned in the uterus such that they can be accessed without being shielded by bowel or bone).
- Fibroids(s) clearly visible on non-contrast MRI.
You may not qualify if…
- Metallic implants that are incompatible with MRI
- Sensitive to MRI contrast agents
- Severe claustrophobia that would prevent completion of procedure in MR unit
- Who are pregnant or desire to become pregnant in the future. Pregnancies following ExAblate treatment could be dangerous for both mother and fetus.
- Pedunculated fibroids
- Active pelvic inflammatory disease (PID)
- Active local or systemic infection
- Known or suspected pelvic carcinoma or pre-malignant conditions, including sarcoma and adenomatous hyperplasia
- Intrauterine device (IUD) anywhere in the treatment path
- Dermoid cyst of the ovary anywhere in the treatment path
- Extensive abdominal scarring that cannot be avoided by redirection of the beam (e.g., due to Caesarean section or repeated abdominal surgeries)
- Undiagnosed vaginal bleeding
Where it is running
- University of California at San Diego — La Jolla, California, United States
- Lahey Clinic — Burlington, Massachusetts, United States
- KNI — Kalamazoo, Michigan, United States
- Cornell Vascular — New York, New York, United States
Full record on ClinicalTrials.gov
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